[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR601.2]

[Page 20-21]
 
                        TITLE 21--FOOD AND DRUGS
 
          DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)
 
PART 601--LICENSING--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 601.2  Applications for biologics licenses; procedures for filing.


    (a) General. To obtain a biologics license under section 351 of the 
Public Health Service Act for any biological product, the manufacturer 
shall submit an application to the Director, Center for Biologics 
Evaluation and Research, on forms prescribed for such purposes, and 
shall submit data derived from nonclinical laboratory and clinical 
studies which demonstrate that the manufactured product meets prescribed 
requirements of safety, purity, and potency; with respect to each 
nonclinical laboratory study, either a statement that the study was 
conducted in compliance with the requirements set forth in part 58 of 
this chapter, or, if the study was not conducted in compliance with such 
regulations, a brief statement of the reason for the noncompliance; 
statements regarding each clinical investigation involving human 
subjects contained in the application, that it either was conducted in 
compliance with the requirements for institutional review set forth in 
part 56 of this chapter; or was not subject to such requirements in 
accordance with Sec. 56.104 or Sec. 56.105, and was conducted in 
compliance with requirements for informed consent set forth in part 50 
of this chapter. A full description of manufacturing methods; data 
establishing stability of the product through the dating period; 
sample(s) representative of the product for introduction or delivery for 
introduction into interstate commerce; summaries of results of tests 
performed on the lot(s) represented by the submitted sample(s); 
specimens of the labels, enclosures, and containers, and if applicable, 
any Medication Guide required under part 208 of this chapter proposed to 
be used for the product; and the address of each location involved in 
the manufacture of the biological product shall be listed in the 
biologics license application. The applicant shall also include a 
financial certification or disclosure statement(s) or both for clinical 
investigators as required by part 54 of this chapter. An application for 
a biologics license shall not be considered as filed until all pertinent 
information and data have been received from the manufacturer by the 
Center for Biologics Evaluation and Research. The applicant shall also 
include either a claim for categorical exclusion under Sec. 25.30 or 
Sec. 25.31 of this chapter or an environmental assessment under 
Sec. 25.40 of this chapter. In lieu of the procedures described in this 
paragraph, applications for radioactive biological products shall be 
handled as set forth in paragraph (b) of this section. The applicant, or 
the applicant's attorney, agent, or other authorized official shall sign 
the application. An application for any of the following specified 
categories of biological products subject to licensure shall be handled 
as set forth in paragraph (c) of this section:
    (1) Therapeutic DNA plasmid products;
    (2) Therapeutic synthetic peptide products of 40 or fewer amino 
acids;
    (3) Monoclonal antibody products for in vivo use; and
    (4) Therapeutic recombinant DNA-derived products.
    (b) Radioactive biological products. To obtain marketing approval 
for a radioactive biological product, as defined in Sec. 600.3(ee) of 
this chapter, the manufacturer of such product shall comply with the 
following:
    (1) An applicant for a radioactive coupled antibody, which means a 
product that consists of an antibody component coupled with a 
radionuclide

[[Page 21]]

component (or an antibody component intended solely to be coupled with a 
radionuclide) in which both components provide a pharmacological effect 
but the biological component determines the site of action, shall submit 
a biologics license application to the Director, Center for Biologics 
Evaluation and Research, Food and Drug Administration, except if, as 
determined by FDA, there are significant scientific issues associated 
with the radionuclide or other chemically synthesized component, in 
which case a new drug application shall be submitted to the Center for 
Drug Evaluation and Research, Food and Drug Administration;
    (2) An applicant for a radioactive biological product other than as 
described in paragraph (b)(1) of this section, shall submit a new drug 
application to the Center for Drug Evaluation and Research, Food and 
Drug Administration.
    (c)(1) To obtain marketing approval for a biological product subject 
to licensure which is a therapeutic DNA plasmid product, therapeutic 
synthetic peptide product of 40 or fewer amino acids, monoclonal 
antibody product for in vivo use, or therapeutic recombinant DNA-derived 
product, an applicant shall submit a biologics license application in 
accordance with paragraph (a) of this section except that the following 
sections in parts 600 through 680 of this chapter shall not be 
applicable to such products: Secs. 600.10(b) and (c), 600.11, 600.12, 
600.13, 610.11, 610.53, and 610.62 of this chapter.
    (2) To the extent that the requirements in this paragraph (c) 
conflict with other requirements in this subchapter (except for those 
products described in paragraph (b) of this section for which a new drug 
application is required), this paragraph (c) shall supersede other 
requirements.
    (d) Approval of a biologics license application or issuance of a 
biologics license shall constitute a determination that the 
establishment(s) and the product meet applicable requirements to ensure 
the continued safety, purity, and potency of such products. Applicable 
requirements for the maintenance of establishments for the manufacture 
of a product subject to this section shall include but not be limited to 
the good manufacturing practice requirements set forth in parts 210, 
211, 600, 606, and 820 of this chapter.
    (e) Any establishment and product license for a biological product 
issued under section 351 of the Public Health Service Act (42 U.S.C. 201 
et seq.) that has not been revoked or suspended as of December 20, 1999, 
shall constitute an approved biologics license application in effect 
under the same terms and conditions set forth in such product license 
and such portions of the establishment license relating to such product.

[64 FR 56450, Oct. 20, 1999]